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Eligible patients are registered with and randomised by the Outreach Trial Co-ordinator, at the Cambridge Cancer Trials Centre (CCTC), CUH.
The OUTREACH trial was a three-arm, randomised controlled trial conducted in two UK hospitals: Cambridge University Hospitals Foundation Trust (CUH) and West Suffolk Hospital NHS Trust (WSH).
Despite these difficulties limiting its size, the OUTREACH trial provides a major contribution to the current evidence base regarding the evaluation of delivering cancer treatment in the community.
However, a consistent feature of all studies evaluating cancer treatment in the community, and confirmed in the OUTREACH trial, is a lack of any evidence suggesting safety concerns.
The Outreach trial is the first randomised trial undertaken in the UK to formally compare delivery of cancer treatment in the community with traditional hospital treatment.
(This formative analysis also drew on qualitative data collected by Wallace and colleagues at the University of London as part of their Virtual Outreach Trial [ 39- 41]).
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On the basis of an average loss to follow-up of 7.2% in the preventive primary care outreach trials in the meta-analysis, we conservatively assumed a 10% loss to follow-up for our sample size calculations.
The tool, available as an online supplement (Additional file 1 ), had previously been applied in South African KMC outreach trials [ 15, 16] and had been adapted for use in Malawi [ 17], Ghana [ 18], Nigeria [ 19], and Indonesia [ 20].
The Improved Delivery of Cardiovascular Care (IDOCC) through Outreach Facilitation trial was designed as a stepped wedge cluster randomized control trial.
The core product is already built, so the funding will be used to do outreach, perform trials, and scale up the operation.
Project LEAD® advocates have worked on protocol and steering committees, data safety monitoring boards, have reviewed and edited educational materials, and have conducted national education and outreach for trials that meet our criteria.
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